FDA.report

Karl Schumacher

Primary DI
00842517110830
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
FEDI2
Device description
Reg Fedi Perio Chisel, I / O, Straight
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842517110830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517110830008425171108308425171108300842517110830

GMDN Terms

TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags

DUNS number
101070070
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23
00842517112629Karl SchumacherNEE06912025-04-23
00842517112780Karl SchumacherNEE07902025-04-23
00842517112803Karl SchumacherNEE07912025-04-23
00842517111417Karl SchumacherHEM06102025-02-05
00842517111424Karl SchumacherHEM06112025-02-05
00842517112209Karl SchumacherMOS06122025-02-05
00842517112216Karl SchumacherMOS06132025-02-05
00842517103603Karl SchumacherAMCBGMS2024-09-19

Other Devices Sharing Product Codes

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04251436931086KOHLERKohler Medizintechnik GmbHEMM2026-03-12
00841013120572Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
00841013120589Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
00841013120596Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
D9282001491H0OSTEOTOME, 7", 4mm SLIGHT CURVE MARKINGS 12-9-6-3mm, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001492H0OSTEOTOME, 7", 4mm, STRONG CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001493H0OSTEOTOME, 7", 4mm, OFFSET, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D928200149H0OSTEOTOME, 7", 4mm STRAIGHT, MARKINGS 12-9-6-3mm, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001501H0OSTEOTOME, 7", 6mm, SLIGHT CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001502H0OSTEOTOME, 7", 6mm, STRONG CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001503H0OSTEOTOME, 7", 6mm, OFFSET, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D928200150H0OSTEOTOME, 7", 6mm, STRAIGHT, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
00841336106260Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMM2025-11-11
00190776401306MillenniumAvalign Technologies, Inc.EMM2025-06-10
D92820029090BURTON PTERYGOID OSTEOTOME 9MMW.H. Holden, Inc.EMM2025-05-21
00190776394646MillenniumAvalign Technologies, Inc.EMM2025-05-07
G586NS38796080NOVOSURGICALNOVO SURGICAL, INC.EMM2025-05-02
00194613108656MSI Precision Specialty InstrumentsMed Saver, Inc.EMM2025-03-21
D928105382010BONE CHISEL 2.5MM, 6" S/EW.H. Holden, Inc.EMM2025-03-19
D928105382020BONE CHISEL 4MM, 6" S/EW.H. Holden, Inc.EMM2025-03-19
EZPF2474485HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
EZPF4774831HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
EZPF4774841HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
D9281675060MINI-LEXER, OSTEOTOME 6mm, STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281675080MINI-LEXER, OSTEOTOME 8mm, STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281675100MINI-LEXER, OSTEOTOME 10mm STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281676060MINI-LEXER, GOUGE 6mmW.H. Holden, Inc.EMM2024-12-18
D9281676080MINI-LEXER, GOUGE 8mmW.H. Holden, Inc.EMM2024-12-18
D9281676100MINI-LEXER, GOUGE 10mmW.H. Holden, Inc.EMM2024-12-18
D9281790900IDR KIT ACCORDING TO DR. ROSAW.H. Holden, Inc.EMM2024-12-18